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Host Cell Residual DNA Quantitation

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resDNASEQ™ Residual DNA Quantitation Systems


The use of biologically derived drugs, in which host cell lines are used to express biological product, has increased dramatically in recent years. This has created a need to quantify residual host cell DNA during manufacturing and in final products.

To ensure product quality, the amount of residual DNA in a drug's final dosage form must meet regulatory guidelines established by the World Health Organization (WHO), the European Pharmacopeia, the US Food and Drug Administration (FDA), and other regulatory agencies.

Precision Counts
Keep quantitation in-house with the resDNASEQ™ Residual DNA Quantitation Systems—the world's first integrated Real-Time qPCR systems for quantitation of residual host cell DNA. The systems combine qPCR-based quantitation with magnetic bead-based sample preparation, which enables you to get precise DNA recovery from complex matrices. This helps you accelerate process characterization and execute rigorous process clearance studies.

The Chinese Hamster Ovary (CHO) Residual DNA Quantitation System includes:
  • Sample preparation, CHO quantitative standard DNA, TaqMan® assay, and master mix
  • Highly sensitive, specific quantitation
  • Optional automated sample preparation delivers up to 24 test results in 5 hours